Tuesday, January 3, 2012

Gluten Testing & our New Lab Tested Gluten Free Logo

This post is part of our ongoing commitment to transparency and consumer education.

A Bit of History

The landscape of the Gluten Free world has changed substantially since 1991 when Kinnikinnick sold its first GF product. Back then, few people (including most doctors) knew what Celiac was, what a GF diet was and GF products were in very short supply.

Ted in 1993 at our first store

When researching his new business, founder Ted Wolff von Selzam made a key decision; the only way to produce gluten free foods is to have a completely dedicated gluten free facility. He knew this would be a challenge, as the market was so (apparently) small, that it would make more sense to just make a few GF items in a regular bakery setting. He believed, and we still do, that while it might have made more economic sense, it wasn't the safe or ethical thing to do.There was also another reason for being so cautious. In Canada, there has been strong GF labelling laws since at least the early 90's and possibly earlier. I couldn't find the date the law was enacted but what it says is this:

A food is not permitted to be labelled, packaged, sold or advertised in a manner likely to create an impression that it is "gluten-free" unless it does not containwheat, including spelt and kamut, or oats, barley, rye, triticale or any part thereof. *

This labelling law is enforced by requiring that any product labelled gluten free have a maximum of 20ppm of gluten. The CFIA (Canadian Food Inspection Agency). The CFIA randomly tests products labelled GF and will recall products that exceed this threshold.

The New Wild West
For 20 years, we developed and produced our line of products while watching something of a wild west in the gluten free market in the U.S. We saw products labelled GF in the U.S. that weren't in Canada (due to inability to meet the Canadian rules?) We've seen bakeries selling products labelled GF that were plainly not (and in several cases tested very high). More recently we've seen an explosion of GF products, many of which are not produced in dedicated GF facilities. Now, let's be clear; there are a number of manufacturers in the U.S. and Canada that have dedicated facilities but many of the products we have seen recently are either co-packed (made on contract by a potentially non-gf manufacturer) or simply made in a non-GF facility. How does a consumer know how great the risk is of cross contamination in these facilities?

Gluten Free Standards and Enforcement
In 2004, the U.S. government passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) which called for a gluten free labelling standard to be in place by 2008. There have been several rounds of "public & industry" consultation but by late 2011, there is still no standard for GF labelling. In summer 2011, the FDA put the legislation out for an additional 60 day comment period but means that standards are still some months away. What happens in a rapidly growing market with no proper regulation? Well, in this case, several entities have stepped in to fill this vacuum and provide consumers some degree of confidence that what they are eating is "safe".

A Whole New Focus for Celiac Support Groups
For years, celiac support groups have been a lifeline to many consumers. In the past, consumers were faced with medical professionals who knew little about the diagnosis, let alone how to advise patients what to do after being diagnosed. In Canada, the Canadian Celiac Association has been pretty much the single point of support, information & advocacy, whereas in the USA a number of national and regional support groups grew up to serve the Celiac community. Over the years, this has led to some confusion due to differing opinions on how to follow a GF diet but it's fair to say that every support group in both the U.S. & Canada has been a tremendous (and often sole) advocate and provider of information & emotional support for those with Celiac disease.

These organizations recognized that Gluten Free consumers needed some assurance that the food that they were eating would meet the strict standards necessary to maintain a healthy GF diet. In response, a number of the organizations developed programs to provide better information to consumers on foods that were labeled as “gluten free”.

A Solution But Not "The" Solution
Starting a few years ago, we started to see support groups creating their own gluten free certification programs. In order to obtain a gluten free certification for a product a company applies to be part of the program, pays a yearly fee and then is subjected to various certification processes. Generally these processes are:

Ingredient review

Site inspection

Product testing

The intent was to make manufacturers aware of the strict standards that are necessary to produce uncontaminated gluten free food. Once this process was complete then the company was free to use the organization’s “gluten free” 3rd party symbol. These programs have been a step forward in producing safer gluten free products. However there is no requirement that food products bearing these certified symbols are produced in a dedicated facility. That is the “gold standard” for ensuring that no cross contamination occurs during the production and packaging processes.

As a point of interest, many of you may have seen a video that we produced several years ago dealing with the difficulty of co packing regular foods and gluten free foods in the same facility.

If this equipment had been used to produce gluten free in a shared facility, would you be comfortable eating it? Now, it's interesting that when we first released this video we saw some fairly vigorous backlash on some GF message boards saying we were fear mongering and trying to scare people away from non-dedicated facilities and trying to limit the gluten free consumers choice. Well, I guess in a way that's true. We -are- trying to get people to buy products from dedicated GF manufacturers. We (not just Kinnikinnick but all dedicated GF producers) take the time and expense to provide the safest food possible. It does not cease to be of central importance for us. We don't believe GF certification of non-dedicated facilities is the answer to safety. The GF market is large enough these days that if you want to be in it you, as a manufacturer, should provide a dedicated facility to ensure customers safety.

Keeping Our Products Safe
Ok, so you probably have guessed by now why we have not applied for 3rd party certification. So how do you, the gluten free consumer, know that Kinnikinnick products are safe? Well to start with, there is our stand on dedicated facilities. If there isn't gluten in the building, it's not going to get in your food while it's being produced. We also don't outsource any manufacturing to other manufacturers. We produce every one of our products in our own facilities.

But what about raw ingredients? Here, I believe, we have been an industry leader in both the kind of testing we do and the openness that we discuss it. As far back as the first year of this blog in 2008, we have been posting about our policies and letting people know how we test. Over the last 20 years we've also written about it numerous times in our newsletter and spoken to hundreds of support groups and trade contacts on the topic. We've openly posted about it on social media like Twitter & Facebook and their predecessor, the Celiac ListServ email list.

A Bit of Testing History
For the first 10 years of our operations, we were limited to identifying and sourcing ingredients from "safer" suppliers. There weren't any tests for gluten that could be done without an extremely expensive lab setup of the kind found in universities and governments. Even then, testing was pretty hit and miss. Enrique Mendez of the University of Madrid developed the R5 monoclonal antibody ELISA (Enzyme-Linked ImmunoSorbent Assay) test in the late 1990's and this was adopted by the Codex Committee of Methods on Analysis and Sampling in 2006. While the test was available, there wasn't even any agreement on how to prepare a standard gliadin sample. In order to have a valid test you need to be able to test it against a known sample prepared using an accepted method. In 2000, a gliadin standard was proposed and formalized in 2006. (For more information see http://www.wgpat.com.ar/aims-history.htm).

We began using ELISA Quick tests as soon as they became available in the market. circa 2001-2002. These tests had a detection limit of between 100 & 200 ppm, so while they were better than nothing, they weren't anywhere near to 20 ppm standard we had to meet under Canadian law. In 2005-2006, we started to see much more accurate testing kits available with detections levels well below 20ppm and we began using these.

State of the Art (or rather Science)

Currently we use 2 testing kits, a qualitative test and a quantitative test. For those of you who don't remember your lab work from school, qualitative tests provide a yes/no answer (is gluten detected) and a quantitative test that can tell you how much. The qualitative test we use is very much like a home pregnancy test in its operation. A sample is prepared in a solvent, a test strip is dipped into the sample and after a few minutes, a coloured indicator appears. If it appears at one spot, there is no gluten detected, at another there is a detection. The quantitative test also has a sample preparation step but the procedure for reading results is much different. Samples are added to a "microwell plate" along with a control sample of gliadin. This plate is place in a special spectrographic reader which analyzes the colours produced by the test and prints out a value of how much gliadin is in the sample. The test that we use the Mendez R5 ELISA test is the only test currently recognized by the Association of Analytical Communities (AOAC). The AOAC is the group that labs worldwide use to provide guidance on standardized testing methods. It's important to note that lack of AOAC approval does not mean that a test is invalid, it simply means that the test has not been accepted as a test method, usually because it is new (and sometimes because it doesn't provide consistently accurate results based on current knowledge)

Some Testing Gotchas
There are some interesting things we've learned over the years in our ongoing quest to be the supplier of the safest gluten free food out there. Things like:

Some tests kits are not suitable for heat treated products, so are not useful for baked products

Some ingredient samples require special preparation as they don't react like other samples (chocolate, spices are but two)

Some test kits are only sensitive to gliadin (the protein in wheat) but miss the protein in barley (horedin), rye (secalin) and oats (avenin - oats are controversial. read about our position here).

Oats are generally not detected by these test kits. We are currently evaluating a new test kit which claims to have better detection of oat proteins.

It's important to note here that as far as we know, "quick test" R5 kits (and possibly other styles of test kits) on the market today are not suitable for heat treated products (ie: all bakery items) or require special extraction methods to provide a valid result. One hopes that all manufacturers and certification organizations are aware of these test kit limitations.

PPM's, LOD's & LOQ's

So what exactly are we testing for and what do the test results mean. In general, all the tests on the market today are looking for gliadin, which is a protein in wheat. This protein is most commonly referred to as gluten, although as inferred above, it encompasses rye & barley and sometimes oats. We've recently seen a product out there claiming "Zero Gluten" (accompanied by lots of !!!!!) The interesting part about that claim is that given the current state of the art, a claim of 0 is impossible if you base it on actual testing. It's also important to realize that for testing, gliadin & gluten are not the same thing. A gliadin result of 5ppm means it contains 10ppm gluten.

To understand what the test results mean, you need to look at Level of Detection (LOD) and Level of Quantification (LOQ). The stated LOD of a test is the lowest possible amount that a test can detect. The LOQ of a test is the amount that the test can actually quantify, or the lowest number that the test can actually say "there is this much of that in this sample". It may be a bit confusing but it makes sense when you look at some numbers.

For the R5 ELISA Quantitative test, the LOD is 1.5ppm gliadin/ 3ppm gluten. This means that the test can not detect gliadin with any certainty below levels of 1.5 ppm. The LOQ for this same test is 2.5 ppm gliadin/gluten. This means that any amount of gliadin above 2.5 ppm can be assigned a value ie: 3.6 ppm. Anything between the LOD and the LOQ will be detected but the test won't be able to give you a value ie: 1.9 ppm.

Another thing to note here is that for the quick tests, there is no LOQ because these tests are only based on detection and not quantification (yes or no vs how much). For the R5 quicktests we use, the LOD is 2.5ppm gliadin or 5ppm gluten.

Supplier Assurance
One of the key parts of our gluten risk management starts with our suppliers. Every manufacturer is required to submit allergen & gluten statements. All of our major suppliers (rice, tapioca, corn, potato, pulses, etc) run dedicated gluten free facilities. However, we do have some suppliers of smaller volume ingredients which do process gluten containing products. This is a fact of doing business in a world where gluten is everywhere. Obviously,when we can use a similar ingredient from a dedicated GF supplier vs. a non-dedicated supplier, we choose the dedicated supplier - even if the ingredient is more expensive. In some cases, there are no alternatives. The only way to manage the risk is with a rigorous testing protocol for all incoming ingredients.

Daily Gluten Testing at Kinnikinnick

Ingredients
When an ingredient arrives at our facility, it is immediately put on hold. One of our lab team is notified and they take samples based on a schedule based on risk and volume. The tests used and the testing method are determined by the type of ingredient. Once a lot number has been tested, it is released or rejected based on the results.

Products
As we've noted previously, we've been testing incoming ingredients in our lab for several year now. Combined with our dedicated gluten free facilities (we don't even let staff bring in sandwiches, cookies etc for lunch!), we are completely confident in our products, however, late last fall we decided to go one step further.Kinnikinnick's New Lab Tested Program and Certification Symbol
In response, to the questions we have had regarding a Certification label we are implementing our own unique Gluten Free symbol which will now appear on all of our products. We believe that it will represent the safest possible food in the gluten free market.

5.Finished
products are sent to a recognized outside lab quarterly to verify our internal test results

Trusting A Manufacturers Logo
So what does this all mean. Is our logo better or worse than a 3rd party certification? Does it mean less than a 3rd party logo? How do you trust something a manufacturer puts on a package?

We have always been willing to provide details on how we do what we do (and this post is just another example).

From a legal standpoint, because we have our production facilities in Canada, we have had to maintain a maximum level of 20 ppm of gluten in our products for the past 20 years to meet government standards. Over the past few years we have improved our supply chain protocols and our testing procedures so that we now are prepared to stand behind a level of less than 5ppm on any of our gluten free products. For 20 years, we have built our company and our reputation on our word. Our new logo is our word that we have done everything in our power to produce the safest gluten free products possible.